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A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials



A Study of Patients Who Develop HIV Infection After Enrolling in HIV Vaccine Trials or HIV Vaccine Preparedness Trials

For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to find out more about how persons respond to HIV-1 infection if they have received an experimental HIV-1 vaccine before they became HIV-infected. It is important to study people who have been given experimental HIV vaccines and who later became HIV-infected for several reasons. First, if HIV infection is found and then cleared, it is important to note the relationship between the virus and the vaccine. This may give an understanding of the immunity. A second reason is to better understand the immune response in those who received a vaccine compared to those who received placebo (no vaccine). If the vaccine does not prevent HIV infection, it will be important to study the progression of the disease. Understanding the immune response in vaccinated patients after infection and the impact on symptoms and disease progression may give valuable information for future vaccine trials and the effectiveness of HIV vaccines.
Details: It is important to study persons vaccinated with candidate HIV-1 vaccines who have become HIV-1 infected for the following reasons. First, if transient HIV-1 infection is detected and then is effectively suppressed or cleared, it will be important to document the antigenic relationship between the breakthrough virus and the vaccine epitopes to attempt to answer questions about the specificity and breadth of the immune response and the determinants of immunity. A second reason is to gain a better understanding of vaccine-induced responses in those participants who are transiently or persistently HIV-1-infected compared to placebo recipients who become HIV-1-infected. If the vaccine does not prevent HIV-1 infection, it will be important to characterize the course of the disease as measured by longitudinal viral load measurements, CD4+ counts, and clinical symptoms. Understanding the breadth, magnitude, and specificity of the immune response in partially or fully immunized vaccinees after infection and the impact on clinical symptoms and disease progression can potentially result in valuable information for the subsequent design of vaccine efficacy trials and, ultimately, in consideration of potential effectiveness of HIV-1 vaccines. Study visits occur at Days 0, 7, 14, 28, then at 2 months, 3 months, 6 months, and every 6 months thereafter. At these visits, patients are given a physical exam, blood is drawn, and a donation of genital fluids is requested at certain visits. Patients are asked to donate samples of either semen (men) or cervical secretions (women); viral load is measured and compared to the amount and types of virus in the blood. He/she may refuse to donate these genital fluids and still be eligible to remain in the study. Primary medical care or medications for HIV infection are not provided by this study.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Participated in HVTN, AVEG, HIVNET Phase I or Phase II vaccine trials or HIV vaccine preparedness trial HVTN 903 and became HIV infected after study enrollment. - Are able and willing to provide information so that they may be located. Exclusion Criteria Patients may not be eligible for this study if they: - Have a medical or mental problem that, in the opinion of the investigator, would interfere with the study.
Total Enrollment: 56

Location and Contact Information:

Overall Study Official:
ConnieCelum,  Study Chair, 

Vanderbilt Univ Hosp *Recruiting*
Nashville,  Tennessee,  3723-2582
United States
Recruiting Kyle  Rybczyk 615-322-5641

San Francisco Dept of Hlth / AIDS Office *Recruiting*
San Francisco,  California,  94102
United States
Recruiting Rose  Quinones 415-544-9014

Columbia Univ *Recruiting*
New York City,  New York,  10032
United States
Recruiting Scott  Hammer 212-305-7185

Univ of Alabama at Birmingham *Recruiting*
Birmingham,  Alabama,  35294
United States
Recruiting Susan  Duncan 205-975-2840

Fred Hutchinson Cancer Research Ctr *Recruiting*
Seattle,  Washington,  98109
United States
Recruiting Julie  McElrath 206-667-6704

New York Blood Ctr / Union Square *Recruiting*
New York City,  New York,  10003
United States
Recruiting Kent  Curtis 212-388-0008

Mt Zion Hospital *Recruiting*
San Francisco,  California,  94102
United States
Recruiting Rose  Quinones 415-544-9014

JHU-CIR/DC *Recruiting*
Baltimore,  Maryland,  21205
United States
Recruiting Eric  Zimmerman 410-955-7283

Fenway Community Health *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Lorrain  Schieve 617-927-6075

Johns Hopkins Univ *Recruiting*
Baltimore,  Maryland,  21205
United States
Recruiting Eric  Zimmerman 410-955-7283

Harvard University / Brigham and Women's Hospital *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting John  Abbatematteo 617-732-5996

Miriam Hosp *Recruiting*
Providence,  Rhode Island,  02906
United States
Recruiting Gail  Yates 401-793-4335

Univ of Rochester Med Ctr *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Catherine  Bunce 585-275-5744

Saint Louis University School of Medicine *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Robert  Belshe 314-577-8648


Additional Information:
Study ID Numbers:
  HVTN 403; 
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029913

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